A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Ramucirumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC

• Advanced NSCLC

• Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.0])

• Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1

• Age ≥ 18 years

• Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)

• Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN)

• Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or trace)

• Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN

• Adequate contraception

• Signed informed consent

Exclusion Criteria:

• Untreated CNS metastases

• Prior bevacizumab therapy

• Radiologically documented evidence of major blood vessel invasion or encasement by cancer

• Prior systemic chemotherapy for Stage IIIB/IV NSCLC

• Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year prior

• Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix

• Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy

• Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Uncontrolled thrombotic or hemorrhagic disorders

• Poorly-controlled hypertension

• Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function

• History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)

• Serious non-healing wound, ulcer, or bone fracture

• Undergone major surgery or subcutaneous venous access device placement. Post-operative bleeding complications or wound complications from a surgical procedures performed in the last 2 months

• Elective or a planned major surgery to be performed during the course of the trial

• Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])

• If female, is pregnant or lactating

• Radiographic evidence of intratumor cavitation

• Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry